Purpose and Scope
The QA Investigations Specialist is responsible for ensuring thorough investigation of CGMP process and product deviations stemming from various departments including but not limited to the following: Patient Safety customer complaints; manufacturing of sterile and dermatological products; Quality Assurance (incoming, floor and finished product); Facilities and utilities; Engineering; Warehouse; Regulatory Affairs and packaging and labeling operations. In general, the QCU laboratories (Chemistry and Microbiology) do not apply.
Essential Duties& Responsibilities
Develop and maintain a robust investigation program that will ensure that investigations are determining root cause, and resulting in the initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process.
Maintain responsibility for providing proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, the issuance of product discards, field actions or recalls.
Create and execute a robust root cause analysis program for CGMP subjects regardless of the associated department, ensuring that the program includes risk management tools.
Teach, mentor and help employees learn how to perform and write acceptable investigations.
Ensure compliance with relevant SOPs while gathering, analyzing and applying information from internal and external sources in order to perform a risk assessment of the impact each deviation and complaint has on the product, process, and patient health and safety.
Ensure that with each investigation, information from all necessary internal and external sources is gathered in order to evaluate the impact of the deviation on previously manufactured product, as well as the risk to future operations.
Assist departments in preparing and analyzing their data (e.g., manufacturing and laboratory analytical historical data), and use methodical root cause analysis tools to determine root causes and effectively communicate the root cause to senior management.
Providing strategic direction, guidance, and facilitation for corrective actions, track completion of and determine the effectiveness and sustainability of corrective actions for CAPAs.
Assess the manufacturing or analytical environment, independently conceive and advise senior management on appropriate corrective/preventative actions designed to mitigate quality deficiencies identified in the investigative process using industry accepted analytical tools.
Provide technical expertise to all Tolmar sites to ensure that investigation corrective and preventative actions are complete, thorough, accurate and timely.
Update SOPs and maintain compliance with various governing procedures and policies as they relate to investigations, and perform trend analysis.
Work independently to comply with procedure-driven guidelines relating to deviation and complaint investigations and make decisions that directly affect patient health and safety.
Provide technical assistance to area supervisors or managers to solve complex problems related to investigations.
Ensure that deadlines are met and closely monitor the need for extensions to be administered in relation to Subsequent Actions and Investigations in order to maintain compliance in this area.
Escalate and involve stakeholders and other functional leaders for resolution, as needed, on issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records.
Ensure the adequacy and effectiveness of CAPA investigations and related corrective and preventive actions in order to meet compliance requirements and prevent recurring non-conforming issues.
Perform other related duties as assigned.
Knowledge, Skills& Abilities
Advanced technical writing skills.
Strong critical thinking and deductive reasoning skills.
Excellent interpersonal and communication (written and verbal) skills
Strong training, coaching and mentoring skills.
Ability to influence and train others. In this role, candidates need to be able to change the behaviors of others through coaching and mentoring.
Must be able to interface positively with Regulatory Agencies, vendors and company departments.
Strong Skill in computer operations in Microsoft Word, Access and Excel.
Working knowledge in drug or device cGMP and ISO 13485.
Advanced knowledge of QA principles, concepts, systems, industry practices, and standards.
Skill in organization and attention to detail.
Ability to work independently.
Procedure and report writing capability.
The QA Investigations Specialist is expected to operate within the framework of Tolmar’s Core Values:
Consistently operate with the highest standards of ethics and compliance.
Take ownership of your actions, success and setbacks.
Respect each other and understand that honest collaboration is at the heart of our company success.
Go the extra mile to make things happen.
Be committed to all we do and the patients we serve.
Embrace change with enthusiasm.
Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
Bachelor’s Degree in Biology, Microbiology, Chemistry, Pharmacy or related field required.
At least 8 years of related experience in CGMP regulated environment.
At least 5 years of experience as a Quality Engineer, CAPA Engineer or equivalent role with demonstrated success leading, driving, and/or implementing the CAPA process in the Medical Device, Pharmaceutical, or Life Science industries required.
Experience as a Quality Engineer, CAPA Engineer or equivalent role with demonstrated success leading, driving, and/or implementing the CAPA process in the Medical Device, Pharmaceutical, or Life Science industries.
Related experience in CGMP regulated environment.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.